Department of Health and Human Services, Centers for Medicare and Medicaid Services: Medicare Program; E-Prescribing and the Prescription Drug Program
GAO-06-252R: Nov 16, 2005
- Full Report:
GAO reviewed the Department of Health and Human Services, Centers for Medicare and Medicaid Services' (CMS) new rule on E-Prescribing and the Prescription Drug Program. GAO found that (1) the rule adopts standards for an electronic prescription drug program under Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003; and (2) with the exception of the 60-day delay in effective date, CMS complied with applicable requirements in promulgating the rule.
Department of Health and Human Services, Centers for Medicare and Medicaid Services: Medicare Program; E-Prescribing and the Prescription Drug Program, GAO-06-252R, November 16, 2005
The Honorable William M. Thomas
The Honorable Charles B. Rangel
Ranking Minority Member
Committee on Ways and Means
House of Representatives
Pursuant to section 801(a)(2)(A) of title 5, United States Code, this is our report on a major rule promulgated by the Department of Health and Human Services, Centers for Medicare and Medicaid Services (CMS), entitled Medicare Program;
E-Prescribing and the Prescription Drug Program (RIN: 0938-AN49). We received the rule on
The final rule adopts standards for an electronic prescription drug program under Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). These standards will be the foundation standards or the first set of final uniform standards for an electronic prescription drug program under the MMA, and represent the first step in CMS's incremental approach to adopting final foundation standards that are consistent with the MMA objectives of patient safety, quality of care, and efficiencies and cost savings in the delivery of care.
The final rule has an announced effective date of
Enclosed is our assessment of the CMS's compliance with the procedural steps required by section 801(a)(1)(B)(i) through (iv) of title 5 with respect to the rule. Our review indicates that, with the exception of the 60-day delay in the rule's effective date, CMS complied with the applicable requirements.
If you have any questions about this report, please contact James W. Vickers, Assistant General Counsel, at (202) 512-8210. The official responsible for GAO evaluation work relating to the subject matter of the rule is Marjorie Kanof, Managing Director, Health Care. Ms. Kanof can be reached at (202) 512-7101.
Kathleen E. Wannisky
Managing Associate General Counsel
ANALYSIS UNDER 5 U.S.C. sect. 801(a)(1)(B)(i)-(iv) OF A MAJOR RULE
ISSUED BY THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES,
CENTERS FOR MEDICARE AND MEDICAID SERVICES
"MEDICARE PROGRAM; E-PRESCRIBING AND
THE PRESCRIPTION DRUG PROGRAM"
(i) Cost-benefit analysis
CMS performed a Regulatory Impact Analysis which noted that it was difficult to precisely predict the monetary impact of the final rule until it becomes clear the degree of participation in e-prescribing by non-mandated providers. However, the analysis discusses the impact on patients, prescribers, and health plans. One benefit cited by CMS is a reduction in the number of adverse drug events (ADEs) with a subsequent reduction in the number of provider visits, hospitalizations, and life-threatening ADEs.
(ii) Agency actions relevant to the Regulatory Flexibility Act, 5 U.S.C. sections 603-605, 607, and 609
The Administrator of CMS has certified that the final rule will not have a significant economic impact on a substantial number of small entities.
(iii) Agency actions relevant to sections 202-205 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. sections 1532-1535
The final rule does not contain either an intergovernmental or private sector mandate, as defined in title II, of more than $120 million in any one year. While the final rule will involve expenditures by the private sector, the expenditures will not approach the $120 million threshold.
(iv) Other relevant information or requirements under acts and executive orders
Administrative Procedure Act, 5 U.S.C. sections 551 et seq.
The final rule was issued using the notice and comment procedures found at 5 U.S.C. 553. On
Paperwork Reduction Act, 44 U.S.C. sections 3501-3520
While the final rule contains an information collection, CMS states that since the standards are in use and constitute a usual and customary business practice, the collection is exempt from review by the Office of Management and Budget (OMB) under 5 C.F.R. 1320.3(b)(2).
Statutory authorization for the rule
The final rule is promulgated under the authority found in section 1860D-4(e) of the MMA (Pub. L. 108-173).
Executive Order No. 12866
The final rule was reviewed by OMB and found to be an economically significant regulatory action under the order.
Executive Order No. 13132 (Federalism)
The final rule will preempt some state laws and, therefore, CMS has prepared a federalism summary impact statement, which is contained in the preamble to the final rule, and discusses the steps taken to minimize conflicts.